Final Acute Care Guidelines for Timely Administration of Scheduled Medications posted on ISMP website
From the May 19, 2011 issue
ISMP extends its sincere thanks to the 150 groups and individuals who provided comments on our draft Guidelines for Timely Medication Administration, which were published in our January 13, 2011 newsletter (www.ismp.org/Newsletters/acutecare/articles/20110113.asp). Approximately 30% of the 150 submissions represented opinions from entire hospital safety teams that met and discussed the guidelines together, or from large professional organizations or agencies, including but not limited to:
- The Joint Commission
- American Nurses Association
- Intravenous Nurses Society
- South Carolina Organization of Nurse Leaders
- New York State Board of Nursing
- Ohio Department of Mental Health
- American Pharmacists Association
- American Society of Health-System Pharmacists
- American Association of Respiratory Care.
The remaining responses were from individual staff nurses, nurse executives, staff pharmacists, directors of pharmacy, and patient safety staff.
With input from an interdisciplinary advisory group, ISMP developed the draft guidelines after conducting a survey in late-2010 regarding the requirement in the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation Interpretive Guidelines to administer medications within 30 minutes before or after the scheduled time. Almost 18,000 nurses who responded to our survey made it clear that changes to drug delivery methods and gradual increases in the complexity of care, number of prescribed medications per patient, and number of patients assigned to each nurse have made the long-standing CMS “30-minute rule” error prone. Many nurses reported feeling great pressure to take shortcuts to comply with the rule, which have led to errors, some harmful. While delaying the administration of certain time-sensitive medications can also result in harm, a one-size-fits-all, inflexible requirement to administer all scheduled medications within 30 minutes of the scheduled time is a precarious mandate given that relatively few medications truly require exact timing of doses.
The vast majority (97%) of those who submitted comments to ISMP, including all of the professional organizations and agencies listed above, were very supportive of the draft guidelines and believed they allowed organizations the flexibility to establish more realistic and safer goals associated with timely medication administration while still allowing nurses to utilize their critical thinking skills to manage their time wisely and prioritize patient needs. Among those who supported the guidelines, about a quarter expressed concern regarding a specific component—most notably the complexity of the goal associated with timely administration of medications prescribed more frequently than every 4 hours (i.e., administer within 25% of the dosing interval). Only four respondents (3%) expressed a general lack of support for the guidelines, either believing the proposed guidelines were wholly unnecessary or not evidence-based. Nevertheless, numerous frontline nurses who provided comments disclosed that the proposed guidelines represent exactly what they feel most nurses follow right now, even if attempts are made to document medication administration more in line with the 30-minute rule.
After thorough review of all the submitted comments, ISMP has made several changes to the draft guidelines, as described below.
Time-critical scheduled medications
The recommendation for hospitals to define their own list of time-critical scheduled medications and to administer these medications at the exact scheduled time when necessary or within 30 minutes of the scheduled time remains unchanged. However, we added several examples of time-critical scheduled medications that should be on all hospitals’ lists, including scheduled (not prn) opioids used for chronic pain or palliative care (fluctuations in the dosing interval may result in unnecessary break-through pain), and medications that must be administered apart from other medications (e.g., antacids and fluoroquinolones). Medications administered more frequently than every 4 hours were also moved to this category of time-critical scheduled medications (see next section). We also emphasized that medications administered around mealtimes require nursing judgment regarding the actual time of administration, which may fluctuate based on meal delivery time, actual consumption of the meal, and the patient’s condition.
Among those that generally supported the draft guidelines, some expressed concern that having three categories of non-time-critical medication types would make the goals of timely administration too complex to remember, enforce, and monitor. To reduce complexity, the final guidelines now suggest that medications prescribed more frequently than every 4 hours should be considered time-critical scheduled medications. The number of medications that would fall into this category is small, and the type of medications that are dosed this frequently often require administration at the exact time, or at least within 30 minutes of the scheduled time, which is the goal for time-critical scheduled medications. This change means there are now only two categories of non-time-critical scheduled medications and proposed goals:
- Daily, weekly, monthly medications: to be administered within 2 hours before or after the scheduled time
- Medications prescribed more frequently than daily, but no more frequently than every 4 hours: to be administered within 1 hour before or after the scheduled time
The draft guidelines included a table of Supporting Operational Guidelines for Timely Administration of Scheduled Medications that provides brief guidance for appropriate allocation of human resources, the content of policies and procedures related to timely drug administration, and evaluation associated with event reporting and data analysis. Changes were made to the event reporting description to streamline the process and remove what was felt to be an unrealistic tracking mechanism based on end-of-shift reports.
The final guidelines include additional language to promote understanding that these guidelines are just that—guidelines, not standards. An interdisciplinary team with nursing representation must translate the guidelines into facility-specific policies and procedures. The guidelines also recommend flexibility of goals for timely administration, as appropriate, to accommodate the additional time needed to learn to operate new medication-related technologies.
We also received numerous comments from practitioners who wanted to remind us that limitations in current information technology associated with medication use would make it difficult to: accommodate more than a single time interval to trigger an alert for delayed and early doses with bar-coding technology; change the appearance of a medication entry for delayed doses in electronic medication administration records (eMARs); and set different time limits for the removal of scheduled medications from automated dispensing cabinets. Challenges also exist with highlighting time-critical medications on eMARs and differentiating between first doses and subsequent scheduled doses when using these technologies. We are aware of these limitations and will be encouraging vendors to address them in updated versions of their technology.
ISMP has posted the final Acute Care Guidelines for Timely Administration of Scheduled Medications on our website at: www.ismp.org/tools/guidelines/acutecare/tasm.pdf. We encourage hospitals to evaluate their goals for timely medication administration using these guidelines, which have been thoroughly vetted by many medication and patient safety experts; hospital safety teams; professional nursing, pharmacy, and respiratory therapy organizations; The Joint Commission; pharmacists; and frontline nurses who bear the ultimate responsibility for administering medications in a timely manner.
Using a modified failure mode and effects analysis process, ISMP has taken steps to anticipate any unintended consequences of changing the goals for timely medication administration. For example, we recognize that dose omissions may be a risk with wider dose intervals but have determined that this risk is lower than the many more serious risks associated with workarounds, shortcuts, and rushed drug administration—the unintended consequences of the “30-minute rule.” However, any change carries the risk of introducing new, unrecognized sources of errors. Thus, we are asking acute care facilities that make changes to their policies based on these guidelines to report any associated concerns, hazards, errors, or adverse events to ISMP via the ISMP Medication Errors Reporting Program (www.ismp.org/merp).
CMS staff has requested a copy of the final guidelines. Based on our recent conversations with them, we are optimistic that positive changes will be made to the “30-minute rule.” For now, hospitals will still be held accountable for the “30-minute rule” in the CMS Interpretive Guidelines. But given the wide support for these more reasonable and clinically appropriate guidelines, we hope CMS surveyors will allow hospitals to justify their carefully considered policies and procedures regarding timely medication administration using these guidelines to anchor the process.